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REGISTER NOW for the course "CEN and ISO Standards for Pre-analytical Processes"



CEN and ISO Standards for Pre-analytical Processes in Industrial Development and Medical Diagnostics


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The course will introduce the European standards for the pre-analytical processing of human biospecimens (CEN/TC 140 Technical Specifications for Preexamination Processes (CEN/TS)) that are presently becoming ISO standards. Their implementation will become relevant once the European In-Vitro Diagnostics Regulation enters into force in 2022.


Besides explaining common structure and specific differences for different sample types and analytical techniques, the rationale and experimental evidence behind selected standards will be presented. With this course participants will obtain a solid understanding of purpose and aims of the standards, and will be able to implement them in their laboratories.


  • Date: May 16, 2018 | 11:00 – 16:00


  • Location: Medical University of Graz, MedCampus, Neue Stiftingtalstrasse 6, 8010 Graz, Austria


  • Registration & CostRegister by e-mail to Course fee: € 320.- including course handouts, coffee and lunch break. After registration you will be provided with the bank details. For definitive registration, the full course fee must be paid in advance, at least 14 days before scheduled course date.


  • Course Programm:

    • Reproducibility of (research) data requires international standards

    • Standardized pre-analytical workflows – what is their benefit beyond mere compliance with upcoming regulations

    • The consensus process of developing European and international standards

    • Scope and common structure of CEN/TS

    • Scientific evidence for pre-analytical standards - examples for different types of biological samples and biomolecules

      • Nucleic acids (DNA, RNA) from tissue

      • Nucleic acids (ccfDNA, RNA) from liquid biopsies

      • Metabolites and Metabolomics from tissue and blood derivatives

    • How to implement CEN/TS compatible workflows

      • Documentation and implementation of CEN/TS common elements

      • Verification and validation of methods

    • Summary and discussion


  • Target Group: Biobank management, diagnostic assay providers, diagnostic laboratories, medical professionals, quality managers.


  • Speakers:
    • Dr. Uwe Oelmüller, QIAGEN GmbH, Germany

    • Univ.-Prof. Dr. Kurt Zatloukal, & Institute of Pathology, Medical University of Graz, Austria

    • Dr. Karl Kashofer, Institute of Pathology, MUG, Austria

    • Univ.-Prof. Dr. Ellen Heitzer, Institute of Human Genetics, Medical University of Graz, Austria

    • Univ.-Doz. Dr. Peter M. Abuja, Institute of Pathology, Medical University of Graz, Austria

    • Mag. Cornelia Stumptner,, Medical University of Graz, Austria

Details about course & speakers >>







Published CEN  Technical Specifications - Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for ….

  •     snap frozen tissue - Part 1: Isolated RNA (CEN/TS 16826-1:2015)

  •     snap frozen tissue - Part 2: Isolated proteins CEN/TS 16826-2:2015)

  •     FFPE tissue - Part 1: Isolated RNA (CEN/TS 16827-1:2015)

  •     FFPE tissue - Part 2: Isolated proteins (CEN/TS 16827-2:2015)

  •     FFPE tissue - Part 3: Isolated DNA (CEN/TS 16827-3:2015)

  •     venous whole blood - Part 1: Isolated cellular RNA (CEN/TS 16835-1:2015)

  •     venous whole blood - Part 2: Isolated genomic DNA (CEN/TS 16835-2:2015)

  •     venous whole blood - Part 3: Isolated circulating cell free DNA from plasma (CEN/TS 16835-3:2015)

  •     metabolomics in urine, venous blood serum and plasma (CEN/TS 16945:2016)